CA2497838C - Application pharmaceutique d'analogues de testosterone a substitution 15 ou 16 - Google Patents

Application pharmaceutique d'analogues de testosterone a substitution 15 ou 16 Download PDF

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Publication number
CA2497838C
CA2497838C CA2497838A CA2497838A CA2497838C CA 2497838 C CA2497838 C CA 2497838C CA 2497838 A CA2497838 A CA 2497838A CA 2497838 A CA2497838 A CA 2497838A CA 2497838 C CA2497838 C CA 2497838C
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CA
Canada
Prior art keywords
dosage unit
hydroxytestosterone
hydroxytestosterones
pharmaceutical dosage
steroid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA2497838A
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English (en)
Other versions
CA2497838A1 (fr
Inventor
Evert Johannes Bunschoten
Herman Jan Tijmen Coelingh Bennink
Rene Frank Van Der Linden
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pantarhei Bioscience BV
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Pantarhei Bioscience BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pantarhei Bioscience BV filed Critical Pantarhei Bioscience BV
Publication of CA2497838A1 publication Critical patent/CA2497838A1/fr
Application granted granted Critical
Publication of CA2497838C publication Critical patent/CA2497838C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/16—Masculine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne des unités posologiques pharmaceutiques destinées à l'administration par voie orale, par voie transmucosale ou par voie transdermique qui renferment des analogues de testostérone à substitution 15 ou 16, ainsi que des méthodes thérapeutiques dans lesquelles on utilise ces analogues de testostérone. La présente invention se rapporte plus particulièrement aux unités posologiques pharmaceutiques qui contiennent au moins 10 µg d'un stéroïde androgénique sélectionné dans le groupe formé par les 15-hydroxytestostérones, les 16-hydroxytestostérones, les précurseurs de ces dernières et les mélanges de ces hydroxytestostérones et/ou de leurs précurseurs; ainsi qu'un excipient pharmaceutiquement acceptable. Le terme "15-hydroxytestostérones" englobe à la fois la 15.alpha.-hydroxytestostérone (15.alpha., 17.beta.-dihydroxy-4-androsten-3-one) et la 15.beta.-hydroxytestostérone (15.beta., 17.beta.-dihydroxy-4-androsten-3-one). De même, le terme "16-hydroxytestostérones" englobe à la fois la 16.alpha.-hydroxytestostérone hydroxytestostérone (16.alpha., 17.beta.-dihydroxy-4-androsten-3-one) et la 16.beta.-hydroxytestostérone (16.beta., 17.beta.-dihydroxy-4-androsten-3-one). Les stéroïdes androgéniques selon la présente invention sont avantageusement employés par exemple, dans une méthode de traitement ou de prévention de la carence androgénique ou dans une méthode de contraception hormonale.
CA2497838A 2002-09-05 2003-09-05 Application pharmaceutique d'analogues de testosterone a substitution 15 ou 16 Expired - Fee Related CA2497838C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP02078643.0 2002-09-05
EP02078643 2002-09-05
PCT/NL2003/000621 WO2004022065A1 (fr) 2002-09-05 2003-09-05 Application pharmaceutique d'analogues de testosterone a substitution 15 ou 16

Publications (2)

Publication Number Publication Date
CA2497838A1 CA2497838A1 (fr) 2004-03-18
CA2497838C true CA2497838C (fr) 2012-07-17

Family

ID=31970390

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2497838A Expired - Fee Related CA2497838C (fr) 2002-09-05 2003-09-05 Application pharmaceutique d'analogues de testosterone a substitution 15 ou 16

Country Status (9)

Country Link
US (1) US7943602B2 (fr)
EP (1) EP1551415B1 (fr)
CN (2) CN1694710B (fr)
AT (1) ATE452641T1 (fr)
AU (1) AU2003263663A1 (fr)
CA (1) CA2497838C (fr)
DE (1) DE60330695D1 (fr)
ES (1) ES2338782T3 (fr)
WO (1) WO2004022065A1 (fr)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE476961T1 (de) 2004-03-10 2010-08-15 Bayer Schering Pharma Ag Flüssige zusammensetzungen als mikroemulsionsvorkonzentrat mit molekular dispergiertem drospirenon
MY142989A (en) 2004-03-10 2011-02-14 Bayer Schering Pharma Ag Stabilised supersaturated solids of lipophilic drugs
US7401307B2 (en) * 2004-11-03 2008-07-15 International Business Machines Corporation Slack sensitivity to parameter variation based timing analysis
US9375437B2 (en) * 2010-06-18 2016-06-28 Lipocine Inc. Progesterone containing oral dosage forms and kits
US8951996B2 (en) 2011-07-28 2015-02-10 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
PT2782584T (pt) 2011-11-23 2021-09-02 Therapeuticsmd Inc Preparações e terapias de substituição para hormonoterapias naturais combinadas
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
WO2014078576A2 (fr) 2012-11-14 2014-05-22 Abon Pharmaceuticals, Llc Système d'administration d'un médicament par voie orale transmuqueuse
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
MX2016014281A (es) 2014-05-22 2017-02-22 Therapeuticsmd Inc Formulaciones y terapias de reemplazo de combinación de hormonas naturales.
US20170035781A1 (en) 2015-06-22 2017-02-09 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
KR20180126582A (ko) 2016-04-01 2018-11-27 쎄러퓨틱스엠디, 인코퍼레이티드 스테로이드 호르몬 약제학적 조성물
US11633405B2 (en) 2020-02-07 2023-04-25 Therapeuticsmd, Inc. Steroid hormone pharmaceutical formulations

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2793216A (en) * 1954-08-17 1957-05-21 Upjohn Co 15-oxy-androstenes and 15-oxy-19-norandrostenes
GB774064A (en) * 1954-08-17 1957-05-01 Upjohn Co Steroids
FR2035786A1 (en) * 1969-03-28 1970-12-24 Squibb & Sons Inc A-d-glucosides of steroids contng 16a-and 17-oh gps
US6117446A (en) * 1999-01-26 2000-09-12 Place; Virgil A. Drug dosage unit for buccal administration of steroidal active agents
JP2003501390A (ja) * 1999-06-04 2003-01-14 ザ ジュネラル ホスピタル コーポレーション 閉経後及び閉経期の女性を治療するための薬学的製剤、及びそれらの利用
CA2669753C (fr) * 1999-09-30 2012-06-26 Hollis-Eden Pharmaceuticals, Inc. Traitement therapeutique d'affections causees par le recepteur androgene

Also Published As

Publication number Publication date
US7943602B2 (en) 2011-05-17
CN1694710B (zh) 2012-09-05
EP1551415B1 (fr) 2009-12-23
ATE452641T1 (de) 2010-01-15
CN101785775B (zh) 2015-03-25
DE60330695D1 (de) 2010-02-04
US20060122158A1 (en) 2006-06-08
CA2497838A1 (fr) 2004-03-18
WO2004022065A1 (fr) 2004-03-18
AU2003263663A1 (en) 2004-03-29
ES2338782T3 (es) 2010-05-12
EP1551415A1 (fr) 2005-07-13
CN101785775A (zh) 2010-07-28
CN1694710A (zh) 2005-11-09

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MKLA Lapsed

Effective date: 20160906